Trial Outcomes & Findings for Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial (NCT NCT00880087)

Last Updated: 2018-06-15

Results Overview

Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest. Higher values of VABS-II represent a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

329 participants

Primary outcome timeframe

Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.

Results posted on

2018-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Therapeutic Hypothermia Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Overall Study STARTED	166	163
Overall Study COMPLETED	166	161
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapeutic Hypothermia Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Hypothermia n=166 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=163 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.	Total n=329 Participants Total of all reporting groups
Age, Continuous	1.4 years n=5 Participants	0.6 years n=7 Participants	1.0 years n=5 Participants
Age, Customized Age Category · < 2 yr	97 Participants n=5 Participants	104 Participants n=7 Participants	201 Participants n=5 Participants
Age, Customized Age Category · 2 - <12 yr	48 Participants n=5 Participants	35 Participants n=7 Participants	83 Participants n=5 Participants
Age, Customized Age Category · 12 - 17 yr	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	64 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	99 Participants n=7 Participants	196 Participants n=5 Participants

PRIMARY outcome

Timeframe: Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.

Population: Subjects with baseline VABS-II \>= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=133 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=124 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Survival With Good Neurobehavioral Outcome Alive with VABS-II >=70 at 1 year	48 Participants	48 Participants
Survival With Good Neurobehavioral Outcome Died or Alive with VABS-II <70 at 1 year	85 Participants	76 Participants

SECONDARY outcome

Timeframe: Measured at one-year anniversary of cardiac arrest.

Population: All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.

Survival at one year after cardiac arrest

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=166 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=161 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Survival Alive at 1 year	81 Participants	74 Participants
Survival Died at 1 year	85 Participants	87 Participants

SECONDARY outcome

Population: All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)

Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome. Since higher levels of VABS-II represent a better outcome, a larger decline (large negative magnitude of change) in VABS-II score from baseline to one year represents a worse outcome.

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=164 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=153 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest 1-year decrease in VABS-II >30 points	12 Participants	8 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest Dead at 1 year	85 Participants	87 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest Lowest possible VABS-II at 1 year	1 Participants	0 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest 1-year decrease in VABS-II 16-30 points	17 Participants	14 Participants
Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest 1-year decrease in VABS-II <=15 points or improved	49 Participants	44 Participants

SECONDARY outcome

Timeframe: Measured at Month 12

Population: Randomized children alive at one year with neuropsychological score available.

Functioning, as assessed by the Mullen Early Learning Composite (for children age \< 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.

Outcome measures

Outcome measures
Measure	Therapeutic Hypothermia n=68 Participants Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=48 Participants Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Neuropsychological Scores (for Participants Who Survive) >115 (above average)	2 Participants	2 Participants
Neuropsychological Scores (for Participants Who Survive) Lowest possible score	18 Participants	8 Participants
Neuropsychological Scores (for Participants Who Survive) <70 (well below average)	18 Participants	11 Participants
Neuropsychological Scores (for Participants Who Survive) 70 - 84 (below average)	9 Participants	14 Participants
Neuropsychological Scores (for Participants Who Survive) 85-115 (average)	21 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at Month 12

Outcome measures

Outcome data not reported

Adverse Events

Therapeutic Hypothermia

Serious events: 85 serious events

Other events: 151 other events

Deaths: 82 deaths

Therapeutic Normothermia

Serious events: 91 serious events

Other events: 146 other events

Deaths: 84 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Rich Holubkov, Professor of Pediatrics

University of Utah

Phone: 807-587-3326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Therapeutic Hypothermia n=161 participants at risk Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=160 participants at risk Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Blood and lymphatic system disorders Coagulopathy	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders DIC	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Leukocytosis	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Arrest cardiac	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Atrial fibrillation	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Atrial perforation	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Bradycardia	1.2% 2/161 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	2.5% 4/160 • Number of events 4 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac arrest	11.2% 18/161 • Number of events 20 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	10.0% 16/160 • Number of events 17 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac failure	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac insufficiency	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac ischaemia	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac ischemia	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac tamponade	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiogenic shock	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiopulmonary arrest	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiopulmonary failure	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Dysrhythmias	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Heart failure	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Myocardial infarction	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Myocarditis	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Recurrent ventricular tachycardia	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Right ventricular failure	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Supraventricular tachycardia	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Tachycardia	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Ventricular dysfunction	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Ventricular tachycardia	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Gastrointestinal disorders Bowel perforation	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Gastrointestinal disorders Hemorrhage intraabdominal	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Gastrointestinal disorders Ischemia bowel	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Gastrointestinal disorders Necrotizing enterocolitis	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Brain death	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Catheter site bleeding	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Clotting of extracorporeal circuit	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Extracorporeal membrane oxygenation complication	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Multi organ failure	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Multi-organ failure	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
General disorders Multiple organ failure	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.9% 3/160 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Infections and infestations Bacterial tracheitis	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.

Other adverse events
Measure	Therapeutic Hypothermia n=161 participants at risk Participants will receive therapeutic hypothermia after experiencing cardiac arrest. Therapeutic Hypothermia: Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.	Therapeutic Normothermia n=160 participants at risk Participants will receive therapeutic normothermia after experiencing cardiac arrest. Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.
Blood and lymphatic system disorders Anemia	6.2% 10/161 • Number of events 10 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	5.6% 9/160 • Number of events 9 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Coagulopathy	6.2% 10/161 • Number of events 10 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	8.1% 13/160 • Number of events 13 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders DIC	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Hemolysis	2.5% 4/161 • Number of events 4 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.9% 3/160 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Leukocytosis	3.1% 5/161 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.9% 3/160 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Leukopenia	1.9% 3/161 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.9% 3/160 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Methemoglobinemia	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Monocytosis	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Neutropenia	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Splenomegaly	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Thrombocytopenia	7.5% 12/161 • Number of events 12 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	6.2% 10/160 • Number of events 10 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Thrombocytopenia aggravated	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Blood and lymphatic system disorders Thrombocytosis	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders AV nodal tachycardia	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Accelerated idioventricular rhythm	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Arrhythmia	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Atrial bigeminy	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Atrial fibrillation	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Atrial flutter	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Atrial tachycardia	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Bradycardia	9.3% 15/161 • Number of events 16 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	3.1% 5/160 • Number of events 5 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac failure	1.2% 2/161 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac insufficiency	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiac tamponade	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	1.2% 2/160 • Number of events 2 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cardiogenic shock	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Congestive cardiac failure aggravated	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cyanosis	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Cyanosis peripheral	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Ectopic atrial beats	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Effusion pericardial	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Extrasystoles	0.00% 0/161 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Heart block	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Heart failure	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Junctional rhythm	1.9% 3/161 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Junctional tachycardia	1.9% 3/161 • Number of events 3 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Left ventricular dysfunction	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.62% 1/160 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.
Cardiac disorders Left ventricular hypertrophy	0.62% 1/161 • Number of events 1 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.	0.00% 0/160 • For all-cause mortality, results reflect vital status at 12 months. Serious adverse events and other (not serious) adverse events were collected for 14 days after treatment was initiated. For adverse events, denominators reflect Safety Population of patients receiving each treatment: 161 patients receiving Therapeutic Hypothermia and 160 patients receiving Therapeutic Normothermia. However, for all-cause mortality at 12 months, denominators can only include those with known 12-month vital status. Since 2 participants who received Therapeutic Normothermia were lost to follow-up at 1 year, the Therapeutic Normothermia denominator for all-cause mortality is 158 rather than 160.